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Underwater EMR vs. Conventional EMR for Large Non-pedunculated Colonic Polyp

Primary Purpose

Colonic Polyp

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Underwater EMR
Conventional EMR
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Polyp focused on measuring Colonic Polyp, Endoscopic mucosal resection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Consecutive patients aged >18 years, diagnosed with a large (>=20 mm) non-pedunculated colonic polyp, who consent to endoscopic mucosal resection of the polyp and willing to participate in this study.

Exclusion Criteria:

  • Polyps showing signs of deep submucosal invasion
  • Inflamatory bowel disease with signs of activity
  • Known or suspected pregnancy
  • Patients unable or unwilling to provide informed consent

Sites / Locations

  • Hospital del Mar. Parc de Salut MarRecruiting
  • Hospital General Universitario de Ciudad RealRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Underwater EMR

Conventional EMR

Arm Description

The patients randomized in this arm will be treated by endoscopic resection assisted by the filling of the colonic lumen using water instead of air and avoiding the formation of a submucosal cushion

The patients randomized in this arm will be treated by endoscopic resection following the traditional technique. It means, by assistance of selective submucosal saline injection to create a submucosal cushion below the polyp.

Outcomes

Primary Outcome Measures

Lesion recurrence rate
Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp)

Secondary Outcome Measures

Technical success rate
Complete removal of polypoid tissue during the procedure
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events (delated hemorrhage, perforation, hospital admission)
En bloc Resection rate
Rate of endoscopic mucosal resection in one piece during the procedure
Procedure time
Time in minutes for the endoscopic mucosal resection
Number of fragments
Number of fragments of the endoscopic mucosal resection
Lesion size
Size of the lesion in millimeters
Thermal artecfacts

Full Information

First Posted
June 13, 2018
Last Updated
July 23, 2019
Sponsor
Parc de Salut Mar
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1. Study Identification

Unique Protocol Identification Number
NCT03567746
Brief Title
Underwater EMR vs. Conventional EMR for Large Non-pedunculated Colonic Polyp
Official Title
Efficacy and Safety of Underwater Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection for the Treatment of Large Non-pedunculated Colonic Lesions. Multicentric Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parc de Salut Mar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To analyse the efficacy and safety of two standard methods of endoscopic mucosal resection (EMR) for large non-pedunculated colorectal polyps, the investigators will compare submucosal injection-assisted endoscopic mucosal resection (SEMR) versus underwater endoscopic mucosal resection, without submucosal injection (UEMR).
Detailed Description
Underwater endoscopic mucosal resection (UEMR) emerges as a variant of traditional resection, in which a submucosal cushion formation is not necessary. This technique was described in 2012 by Kenneth Binmoeller based on the physical floating effect of colonic mucous membrane by filling the colonic lumen using water instead of air. This "floating effect" conditions the natural separation of the colonic wall layers, allowing the distension of the submucosal space without the need to inject substances into it. On the other hand, performing resection in liquid medium conditions could drive the benefit of heat dissipation caused by the current, which would reduces thermal damage caused to the tissues.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp
Keywords
Colonic Polyp, Endoscopic mucosal resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
356 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Underwater EMR
Arm Type
Experimental
Arm Description
The patients randomized in this arm will be treated by endoscopic resection assisted by the filling of the colonic lumen using water instead of air and avoiding the formation of a submucosal cushion
Arm Title
Conventional EMR
Arm Type
Active Comparator
Arm Description
The patients randomized in this arm will be treated by endoscopic resection following the traditional technique. It means, by assistance of selective submucosal saline injection to create a submucosal cushion below the polyp.
Intervention Type
Procedure
Intervention Name(s)
Underwater EMR
Intervention Description
Polypectomy is performed under full water emersion avoiding the use of submucosal injection.
Intervention Type
Procedure
Intervention Name(s)
Conventional EMR
Intervention Description
It will be performed in a 2-step procedure. First the formation of a submucosal injection underneath the polyp to create a submucosal safety cushion. Then EMR is performed with a polipectomy snare.
Primary Outcome Measure Information:
Title
Lesion recurrence rate
Description
Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Technical success rate
Description
Complete removal of polypoid tissue during the procedure
Time Frame
1 hour
Title
Incidence of Treatment-Emergent Adverse Events
Description
Incidence of Treatment-Emergent Adverse Events (delated hemorrhage, perforation, hospital admission)
Time Frame
1 year
Title
En bloc Resection rate
Description
Rate of endoscopic mucosal resection in one piece during the procedure
Time Frame
1 hour
Title
Procedure time
Description
Time in minutes for the endoscopic mucosal resection
Time Frame
1 hour
Title
Number of fragments
Description
Number of fragments of the endoscopic mucosal resection
Time Frame
1 hour
Title
Lesion size
Description
Size of the lesion in millimeters
Time Frame
1 hour
Title
Thermal artecfacts
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consecutive patients aged >18 years, diagnosed with a large (>=20 mm) non-pedunculated colonic polyp, who consent to endoscopic mucosal resection of the polyp and willing to participate in this study. Exclusion Criteria: Polyps showing signs of deep submucosal invasion Inflamatory bowel disease with signs of activity Known or suspected pregnancy Patients unable or unwilling to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joaquin Rodriguez, MD PhD
Phone
926278000
Ext
79114
Email
joakinrodriguez@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marco A Alvarez-Gonzalez, MD PhD
Email
marcoalgo@gmail.com
Facility Information:
Facility Name
Hospital del Mar. Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco A Alvarez-Gonzalez, MD PhD
Phone
0034 932483000
Email
marcoalgo@gmail.com
Facility Name
Hospital General Universitario de Ciudad Real
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquin Rodriguez Sanchez, MD PhD
Email
joakinrodriguez@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Underwater EMR vs. Conventional EMR for Large Non-pedunculated Colonic Polyp

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